Q: How to Apply Lean Innovation Methods To Regulated Industries

Q: My research focused on the assessment of atherosclerosis in coronary arteries using Computed Tomography examinations as the imaging modality. I have looked at various aspects of atherosclerosis such as volume scores, automatic extraction of anatomical structures, plaque detection, dual energy CT and plaque distribution patterns. I am new to the lean innovation methods and am having difficulty applying methods like minimum viable product (MVP) in my industry, medical imaging, which is heavily regulated. I cannot see how to do incremental updates given the level of regulatory sign-off required.

We have worked with a number of medical instrument and “medical workflow” startups who face this challenge in different ways. And our work on the BeamWise team has led to a number of conversations with medical imaging and instrumentation companies developing new products.

Lean Innovation: Established Firms Vs. Startups

An established firm with existing customers should invest effort in instrumenting current offerings to get a better handle on actual use and duty cycle, and allow the technicians/researchers/doctors to provide feedback in context (at point of care or point of use) for shortcomings or issues. More simply, take a hard look at how folks are using your current product before proposing something new.

Startups need to separate the challenges of image collection from the usability. For new modalities of image collection you need to work with research groups to be able to get access to tissue samples or live subjects depending upon your application. Often a veterinary or agricultural application is an easier way in than aiming directly at human subject applications, once you have established the usefulness finding teams that want to work with you on human subjects becomes easier. If your primary worry (or innovation) is more about usability or image presentation then you can work from “canned” image data sets and pay technicians, researchers, or doctors to take part in feedback sessions where they interact with the images produced (perhaps in the context of your user interface) and give you feedback.

Net net, even though the final configuration is subject to rigorous review you can find ways to test different critical aspects of your product and iterate without having to get final approval.

Consider Attending Great Demo Workshop

You might also consider our October 15-16 “Great Demo” workshop, a number of medical imaging firms have attended over the years and have found that Peter Cohan offered a number of valuable insights they were able to incorporate into their discovery conversations and demos of new products.